Effect of His Bundle Pacing in Treatment of Slow Arrhythmia on Function of Left Atrial and Ventricle in Short Term

Comparsion of the Effects of the Histobal Pacing and Double-lumen Pacing on the Function of Left Atrium in Short Term

Bradyarrhythmia is one of the common diseases. Also, bradyarrhythmia could result in syncope, clinic convulsion, shock, sudden death and so on, which could influence people's life quality severely. Artificial pacemaker is the only way that can cure bradyarrhythmia. However, traditional right ventricular apical pacing, because its electric stimulation is mostly different of the physiological one, could lead to ventricular thick inhomogeneously. At the same time, traditional right ventricular apical pacing also could result in cardiac arrhythmia and fibrosis, dyssynchrony of the ventricles, which can increase the volume of mitral regurgitation. Besides, cardiac resynchronization therapy (CRT), which aims to cure chronic heart failure, is also unsatisfactory. On the contrary, the electric stimulation of his bundle pacing (HBP) is the same as the physiological one, which produces a relatively normal electrical stimulation and synchrony in systolic velocities in ventricular. Thus, HBP could produce a better haemodynamic effect, which is the hotspot in pace-making area recently.

The purpose of this study is to conduct a comparison in patients' cardiac function, ECG, and pacemakers' threshold value, time limit and so on among dual chamber pacemaker and HBP.

Study Overview

• Status: Completed
• Conditions: Slow Arrhythmia; His Bundle Pacing; Function of Left Atrial and Ventricle
• Intervention / Treatment: Device: Dual Chamber Pacemaker; Device: His Bundle Pacemaker

Detailed Description

The purpose of this study is to conduct a comparison in patients' cardiac function, ECG, and pacemakers' threshold value, time limit and so on among dual chamber pacemaker and HBP.

The clinic trial is about to conduct pacemaker implantation in 84 participants, which distribute into dual chamber pacemaker, HBP 2 groups in proportion of 1:1 in random. All of the participants are supposed to conduct ultrasonic cardiogram (UCG), ECG, BNP and pacemaker programing.

Methods: conduct pacemaker implantation in 84 patients, which distribute into dual chamber pacemaker, HBP 2 groups in proportion of 1:1 in random. Patients with The implanting progress of dual chamber pacemaker: 1. Conducting venipuncture. Subclavian vein is our first choice. Then investigator will set up two venous channels and implant two guiding wires into postcava. 2.Putting 2 sheathing canals into heart along with guiding wires. 3.Locating the sheathing canals, and putting electrodes into canals. 3.Adjusting the electrodes and revolving them anticlockwise to lead them to right atrium and right ventricle respectively under the X-ray. 4.Immobilizing electrodes. 5. Some ways to determine whether the electrode is fixed or not: the head of the electrodes could beat rhythmically with atrium or ventricle or by testing damage current. 6.Removing the canals and suturing.

The implanting progress of HBP: 1. Conducting venipuncture. Subclavian vein is our first choice. Then investigator will set up two venous channels and implant two guiding wires into postcava. One of the guide wire is 120cm in length, 0.035 or 0.038 in diameter, which is required to lead the C315 sheathing canal. 2.Putting C315 sheathing canal into heart along with guiding wires. 3.Locating the C315 sheathing canal, and adjusting the head of C315 towards ideal pacing location. 3.Implanting the spiral electrodes and fixing them. Leading the spiral electrode (type 3830 on Medtronic) to the side of his bundle along the C315 canal under the X-ray. The other electrode is leaded to right atrium like dual chamber pacemaker under the X-ray. 4.Revolving the 3830 electrode suitably to Immobilizing it in cardiac muscle. If the electrode can get the his electric potential and produce his bundle pacing successfully, investigator revolve the 3830 electrode and immobilize it. 5. Some ways to determine whether the electrode is fixed or not: the head of the electrodes could beat rhythmically with atrium or ventricle or by testing damage current. 6.Removing the canals and suturing.

Both of the dual chamber pacemaker and the HBP should ensure to keep 100% pacemaking rate in 60-70 bpm heart rate.

All of the participants are supposed to be tested ECG, UCG and some pacemaker programming on pre-operation and 7 days after the operation.

Collection of relevant data:

Threshold value, sense and damage current of pacemaker. Two technologists of the pacemaker detect the threshold value, sense and damage current of the pacemakers respectively. Then all the data will be collected in average value.

UCG: testing the sizes of left atrium (LA), right atrium (RA), left ventricle (LV), right ventricle (RV) before and after the operation. Besides, the ejection fraction (EF) of LV and LA, and E peak, A peak and velocity time integral (VTI) of LA will be tested during the examination. All of the examination will be completed by one cardiologist and one physician of cardiac uhrasonography. Meanwhile, patients should complete BNP testing during the follow-up visit pre-operation and 7 days after the operation.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China
      • Second Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with sinus node disfunction: sinus node disfunction with obvious clinical symptoms, including sinus pause; patients with chronotropismus disfunction; patients have to take some medicine due to some diseases, but the medicine may result to sinus bradycardia.
2. Adult Acquired Atrioventricular Block (AVB):

2.1.Third degree or advanced atrioventricular block in any block part with symptomatic bradycardia

2.2.Patients taking other antiarrhythmic drugs in long term, which could result in third degree or advanced AVB (in any block part) and symptomatic bradycardia;

2.3.Patients with carotid sinus hypersensitivity or neurogenic syncope of the heart;

Exclusion Criteria:

1.Patients with congenital heart diseases,such as arial septal defect,ventricuar defect, rheumatic heart diseases, and valvular heart diseases,such as MS, MI, TS, TI.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dual chamber pacemaker; Patients with sinus node disfunction: sinus node disfunction with obvious clinical symptoms, including sinus pause; patients with chronotropismus disfunction; patients have to take some medicine due to some diseases, but the medicine may result to sinus bradycardia.; Adult Acquired Atrioventricular Block (AVB): (1). Third degree or advanced atrioventricular block in any block part with symptomatic bradycardia (2). Patients taking other antiarrhythmic drugs in long term, which could result in third degree or advanced AVB (in any block part) and symptomatic bradycardia;; Patients with acute myocardial infarction (AMI) and AVB: (1). Patients with His-Purkinje system persistent second degree AVB and retardant or third degree AVB after STEMI; (2). Patients with temporary severe second degree AVB or third degree AVB (block part under atrioventricular node) and retardant; 4. Patients with carotid sinus hypersensitivity or neurogenic syncope of the heart;	Device: Dual Chamber Pacemaker; 1. Conducting venipuncture. Subclavian vein is our first choice. Then we set up two venous channels and implant two guiding wires into postcava. 2.Putting 2 sheathing canals into heart along with guiding wires. 3.Locating the sheathing canals, and putting electrodes into canals. 3.Adjusting the electrodes and revolving them anticlockwise to lead them to right atrium and right ventricle respectively under the X-ray. 4.Immobilizing electrodes. 5. Some ways to determine whether the electrode is fixed or not: the head of the electrodes could beat rhythmically with atrium or ventricle or by testing damage current. 6.Removing the canals and suturing.
Experimental: His bundle pacemaker; His Bundle Pacemaker: All of the Criteria Inclusion of dual chamber pacemaker excluding patients with block part under the his bundle;	Device: His Bundle Pacemaker; 1.Conducting venipuncture. Subclavian vein is our first choice. Then we set up two venous channels and implant two guiding wires into postcava. One of the guide wire is 120cm in length, 0.035 or 0.038 in diameter, which is required to lead the C315 sheathing canal. 2.Putting C315 sheathing canal into heart along with guiding wires. 3.Locating the C315 sheathing canal, and adjusting the head of C315 towards ideal pacing location. 3.Implanting the spiral electrodes and fixing them. Leading the spiral electrode to the side of his bundle along the C315 canal under the X-ray. The other electrode is leaded to right atrium like dual chamber pacemaker under the X-ray. 4.Revolving the 3830 electrode suitably to Immobilizing it in cardiac muscle. If the electrode can get his electric potential and produce his bundle pacing successfully, we revolve the 3830 electrode and immobilize it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of ECG	time limit of QRS in ms, PR duration in ms, QRS duration and QT duration in ms	baseline,1 and 7 days after the operation
Changes of the Data of Pacemaker	Threshold value in V, sense in mV of the pacemaker	1 and 7 days after the operation
Changes of UCG	UCG:sizes of LA,RA,LV,RV in mm, and ejetion fraction of LV and LA (%), and E peak, A peak in mm and velocity time integral (VTI) of LA	baseline,1 and 7 days after the operation
Changes in BNP	BNP in pg/ml	baseline,1 and 7 days after the operation

Collaborators and Investigators

• Sponsor: The Second Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: August 25, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: XieRuiqindoctorHBP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes